How Should AFINITOR Be Taken?

 

TREATMENT WITH AFINITOR

How to Take AFINITOR DIZPERZ

See detailed instructions on how to prepare and take your dose.

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How Should AFINITOR Be Taken?

Your health care provider will prescribe the dose of AFINITOR or AFINITOR DISPERZ that is right for you. Take AFINITOR or AFINITOR DISPERZ exactly as your health care provider tells you to. Your health care provider may change your dose of AFINITOR or AFINITOR DISPERZ or tell you to temporarily interrupt dosing, if needed.

Take AFINITOR or AFINITOR DISPERZ one time each day at about the same time. Take AFINITOR or AFINITOR DISPERZ the same way each time, either with food or without food. Use scissors to open the blister pack.

AFINITOR

  • Swallow AFINITOR tablets whole with a glass of water. Do not crush AFINITOR tablets. Do not take any tablet that is broken or crushed

AFINITOR DISPERZ

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  • If your health care provider prescribes AFINITOR DISPERZ for you, see the "Instructions for Use" that come with your medicine for instructions on how to prepare and take your dose
  • Each dose of AFINITOR DISPERZ must be prepared as a suspension before it is given
  • AFINITOR DISPERZ can cause harm to an unborn baby. When possible, the suspension should be prepared by an adult who is not pregnant or planning to become pregnant
  • Anyone who prepares suspensions of AFINITOR DISPERZ for another person should wear gloves to avoid possible contact with the medicine

If you take too much AFINITOR or AFINITOR DISPERZ contact your health care provider or go to the nearest hospital emergency department right away. Take the pack of AFINITOR or AFINITOR DISPERZ with you.

If you miss a dose of AFINITOR or AFINITOR DISPERZ, you may still take it up to 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your AFINITOR or AFINITOR DISPERZ, skip the dose for that day. The next day, take AFINITOR or AFINITOR DISPERZ at your usual time. Do not take 2 doses to make up for the one that you missed. If you are not sure about what to do, call your health care provider.

You should have blood tests before you start AFINITOR or AFINITOR DISPERZ and as needed during your treatment. These will include tests to check your blood cell count, kidney and liver function, cholesterol, and blood sugar levels. You will also need to have blood tests regularly to measure how much medicine is in your blood. This will help your health care provider decide how much AFINITOR or AFINITOR DISPERZ you need to take.

Important Safety Information

AFINITOR or AFINITOR DISPERZ can cause serious side effects, which can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Patients should follow their health care provider's instructions.

Please see additional Important Safety Information.

Please see full Prescribing Information for AFINITOR, including Patient Information.

 

How is AFINITOR dosed?

Not all patients taking AFINITOR or AFINITOR DISPERZ will take the same dose. Your doctor will determine the correct dose of AFINITOR or AFINITOR DISPERZ for you or your loved one based on height and weight. Your doctor may adjust this dose depending on the response to the medication, side effects, changes in other medications you are taking, or the amount of drug in the blood. Tests that measure the level of AFINITOR or AFINITOR DISPERZ in the blood allow the doctor to determine the appropriate dose for each person. You or your loved one will need to have blood tests regularly to measure how much medicine is in the blood.

You can help ensure that you or your loved one are getting the appropriate dose of AFINITOR or AFINITOR DISPERZ. Let your doctor or nurse know right away if you or your loved one experience any side effect that's bothersome or does not go away. Your health care provider may change your dose of AFINITOR or AFINITOR DISPERZ, or stop prescribing it.

Important Safety Information

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR or AFINITOR DISPERZ with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John's wort (Hypericum perforatum), medicines that weaken your immune system (your body's ability to fight infections and other problems), or medicines for:

  • Fungal infections
  • Bacterial infections
  • Tuberculosis
  • Seizures
  • HIV-AIDS
  • Heart conditions or high blood pressure

If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR or AFINITOR DISPERZ may need to be changed. Tell your health care provider before you start taking any new medicine.

Please see additional Important Safety Information.

Please see full Prescribing Information for AFINITOR, including Patient Information.

 

SEGA With TSC

AFINITOR® (everolimus) Tablets and AFINITOR DISPERZTM (everolimus tablets for oral suspension) are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.

Important Safety Information

AFINITOR can cause serious side effects, including lung or breathing problems, infections, and kidney failure, which can lead to death. Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR are at a possible increased risk for a type of allergic reaction called angioedema. AFINITOR can cause incisions to heal slowly or not heal well. Mouth ulcers and mouth sores are common side effects, occurring in up to 78% of patients taking AFINITOR. AFINITOR can affect blood cell counts, kidney and liver function, and blood sugar and cholesterol levels. Regular blood tests should be performed before starting AFINITOR and as needed during treatment to check blood cell count, kidney and liver function, blood sugar and cholesterol levels, and how much AFINITOR is in the blood.

Please see additional Important Safety Information.

Please see full Prescribing Information for AFINITOR, including Patient Information.

 
 

Important Safety Information

Patients should not take AFINITOR or AFINITOR DISPERZ if they are allergic to AFINITOR or AFINITOR DISPERZ or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR or AFINITOR DISPERZ if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).

AFINITOR or AFINITOR DISPERZ can cause serious side effects that can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Patients should follow their health care provider's instructions. Serious side effects include:

Lung or Breathing Problems: In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their health care provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing.

Infections: AFINITOR or AFINITOR DISPERZ may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their health care provider right away if they have a temperature of 100.5°F or above, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.

Angioedema: Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR or AFINITOR DISPERZ are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR or AFINITOR DISPERZ if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR or AFINITOR DISPERZ.

Kidney Failure: Patients taking AFINITOR or AFINITOR DISPERZ may develop kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR or AFINITOR DISPERZ.

Delayed Wound Healing: AFINITOR or AFINITOR DISPERZ can cause incisions to heal slowly or not heal well. Call your health care provider right away if your incision is red, warm, or painful; if you have blood, fluid, or pus in your incision; if your incision opens up; or if your incision swells.

Before taking AFINITOR or AFINITOR DISPERZ, tell your health care provider about all your medical conditions, including if you:

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR or AFINITOR DISPERZ with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John's wort (Hypericum perforatum), medicines that weaken your immune system (your body's ability to fight infections and other problems), or medicines for:

  • Fungal infections
  • Bacterial infections
  • Tuberculosis
  • Seizures
  • HIV-AIDS
  • Heart conditions or high blood pressure
 

If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR or AFINITOR DISPERZ may need to be changed. Tell your health care provider before you start taking any new medicine.

Common Side Effects: Common side effects include mouth ulcers. AFINITOR or AFINITOR DISPERZ can cause mouth ulcers and sores. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other common side effects include:

  • Infections
  • Nausea and vomiting
  • Diarrhea and constipation
  • Swelling of your hands, arms, legs, and feet
  • Joint pain
  • Cough
  • Skin problems (such as rash, acne, or dry skin)
  • Fever
  • Feeling tired
  • Anxiety, aggression, and other abnormal behaviors
  • Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your health care provider if this happens
  • Low red blood cells, white blood cells, or platelets
  • Increased blood cholesterol level and certain other blood levels
  • Increased blood sugar levels
  • Decreased blood phosphate level
 

Tell your health care provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of AFINITOR or AFINITOR DISPERZ. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for AFINITOR, including Patient Information.

The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis.

Indication

AFINITOR and AFINITOR DISPERZ are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.

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